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FDA 510(k)

Xenco Medical InterAlign Cervical Interbody System

K-Number: K223059 · 2023-06-07

ApplicantXenco Medical, LLC
Decision Date2023-06-07
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical InterAlign Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K223059. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenco Medical InterAlign Cervical Interbody System?

Xenco Medical InterAlign Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Xenco Medical, LLC. The 510(k) number is K223059.

When did Xenco Medical InterAlign Cervical Interbody System receive FDA 510(k) clearance?

Xenco Medical InterAlign Cervical Interbody System received FDA 510(k) clearance on 2023-06-07, under 510(k) number K223059.

Who is the listed applicant for Xenco Medical InterAlign Cervical Interbody System?

The FDA 510(k) record lists Xenco Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenco Medical InterAlign Cervical Interbody System?

The FDA product code for Xenco Medical InterAlign Cervical Interbody System is OVE.

Other records listing Xenco Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243673Xenco Medical CancelleX Cervical Interbody SystemK213456Xenco Medical Multilevel CerviKitK191074Sorrento Bone Graft SubstituteK190364CancelleX Porous Titanium Lumbar Interbody DeviceK173933Sorrento Bioglass Bone Graft SubstituteK180373CancelleX Porous Titanium Lumbar Interbody Device

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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